Derivation of New Human Embryonic Stem Cell Lines Lines for Clinical Use
Human embryonic stem cells (hESCs) are isolated from the early human embryo and have the capability to proliferate indefinitely in culture and to develop into nearly every cell of the human body. Therefore, hESCs may serve as a renewable unlimited source of cells for transplantation therapy. Because of the use of animal products in their derivation, and due to the lack of appropriate quality and process controls in the manufacturing of existing cell lines worldwide, existing hESC lines are not suitable for utilization in transplantation therapy.
Our objective is to derive several new hESC lines that will be suitable for clinical trials. The investigators plan on deriving the new hESC lines utilizing only FDA-approved raw materials in a non-animal culture system. They will be produced entirely under GMP conditions, using appropriately documented procedures and analytical methods, completely safety tested, and screened for infectious and adventitious agents.
|Official Title:||The Derivation of New Human Embryonic Stem Cell Lines for Clinical Use|
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353197
|Contact: Benjamin E. Reubinoff, M.D. PhD.||011-972-2-677-7111 ext firstname.lastname@example.org|
|Contact: Nitzchiya Geva, B.S.N.||011-972-2-677-7111 ext 7174||NitshiaG@hadassah.org.il|
|Hadassah Medical Organization||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DMD 011-972-2-677-7111 ext 76095 email@example.com|
|Contact: Hadas Lemberg, PhD 011-972-2-677-7111 ext 77572 firstname.lastname@example.org|
|Principal Investigator: Benjamin E. Reubinoff, M.D. PhD.|
|Principal Investigator:||Benjamin E. Reubinoff, M.D. PhD.||Hadassah Medical Organization|